Apparatus and method for catheterization of blood vessels

ABSTRACT

A catheter insertion device is disclosed herein. The device allows an operator to insert a catheter within a vessel with a single hand enabling the operator to keep a grip on the patient&#39;s skin and vessel. The device also includes a needle tip sheath that protects operators from accidental needle punctures by contaminated needles.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] This invention relates to medical catheters, more particularly toa catheter insertion device that protects users from accidental needlepricks, provides a gauge for multiple-attempt catheterizations, andprovides a quick-taping system.

[0003] 2. Prior Art

[0004] Administering intravenous medications and agents or installingintravenous monitoring devices requires the catheterization of veins orarteries (generally “vessels”). Intravenous catheters (usually flexiblecatheters) must be inserted into a vessel and must be positionedproperly to establish and maintain the proper fluid flow through thecatheter that remains in the vessel. One type of catheter insertiondevice comprises a needle and a plastic catheter tube that slides overthe needle so that the needle point protrudes through the catheter.Introduction of the catheter into the vessel requires manipulation andpositioning of the vessel as well as precise placement of the needle andcatheter within the vessel. Once properly placed, the operator mustcarefully withdraw the needle and leave the catheter within the vessel.

[0005] Medical personnel (“operator”) operate catheters as follows. Theoperator grips the posterior portion of the intravenous catheter withone hand and secures and holds the skin and vein of the patient with theother hand. The operator inserts and guides the needle tip through thepatient's skin and into a vessel. Blood flows from the vessel throughthe passageway in the needle and into a catheter collection chamber. Theoperator advances the needle slightly to assure that the catheter hasentered the vessel. The operator inserts the catheter into the vesselwithout advancing the needle. This additional insertion of the catheteris difficult and contributes to misstarts, which require the withdrawaland reinsertion of the intravenous catheter into the vessel. Thus, thepatient may endure additional needle punctures.

[0006] With a majority of intravenous insertion attempts, operators mustremove the hand that holds the patient's skin and vein and use that handto remove the needle from the catheter. Because the operator is notgripping the patient's skin and vein, the catheter may slip from withinthe vessel and cause a misstart.

[0007] After removing the needle, the operator places it on a medicaltray or hands it to an assistant. The removal and placement of theneedles is usually done haphazardly because operators are focused onpreventing withdrawal of the catheter from the vessel. Consequently,operators and assistants have been injured from needle pricks bycontaminated needles. Thus, a need exists for a medical catheter thatcan minimize misstarts while at the same time preventing contaminatedneedles from injuring medical personnel.

ADVANTAGES AND OBJECTS OF THE INVENTION

[0008] The present invention has advantages over prior art devices. Aprotective sheath covers the needle tip when the needle has been removedfrom the catheter to prevent injuries to medical personnel. The designof the present device allows medical personnel to withdraw the needlefrom the catheter without moving the hand that holds the patient's skinand vessel. Therefore, the present invention decreases the risk ofmisstarts when withdrawing the needle from the catheter.

[0009] The present invention may be used in connection with a variety ofintravenous catheters and needles, including catheters and needles ofdifferent sizes, lengths, and gauges. The catheter insertion device isconstructed with a thumb ring that enables an operator to retract thecatheter back to its starting point (when the locking member has notbeen engaged) after the catheter has been partially discharged usingonly a single hand. The present invention also incorporates a gaugepositioned thereon to allow operators to safely identify the point atwhich it is safe and acceptable to return the device to a startingpoint. The present invention has an extended blood backflow chamber thatallows multiple cannulation attempts without removing the catheter froma patient's tissue.

[0010] The present invention incorporates a fastening member that allowsthe catheter to be fixedly positioned (relative to the vessel in whichthe catheter has been positioned) within seconds after the catheter hassuccessfully cannulated the blood vessel. A clamp may also be used tofluidly seal the catheter and prevent blood backflow from the vessel outthrough the catheter.

[0011] With the aforementioned considerations in mind, it is thereforean object of this invention to provide an intravenous catheter devicethat enables the operator to withdraw the needle using one hand withoutreleasing the grip on the patient with the other hand.

[0012] It is a further object of the present invention to provide anintravenous catheter device that clamps and holds the catheter.

[0013] It is a further object of the present invention to provide anintravenous catheter device that can adapt to existing catheters andallow medical professionals to choose their own catheters.

[0014] It is a further object of the present invention to provide anintravenous catheter device that allows an operator to secure thecatheter immediately after vessel catheterization without releasing thegrip on the patient's arm.

[0015] These and other advantages and objects of this invention shallbecome apparent from the ensuing description of the invention.

SUMMARY OF THE INVENTION

[0016] The present invention is a catheter insertion device comprising:(a) a shaft having a first end and a catheter end, wherein the catheterend is configured to releasably engage a hollow catheter having a tip;(b) a sheath positioned on the shaft configured to have a passagetherethrough and positioned to align the passage with a catheter; (c) abody slidably positioned on the shaft, attachable to a needle, andconfigured to align a needle with the passage in the sheath and with thecatheter wherein the needle, the sheath, the shaft and the catheter aresized and spaced to position a needle tip of a needle beyond thecatheter tip when the body is advanced toward the catheter end of theshaft, and to remove the needle tip from within the catheter and toposition the needle tip within the passage of the sheath when the bodyis retracted toward the first end of the shaft.

[0017] The invention also comprises a method for intravenously insertinga catheter using the catheter insertion device. The method comprises thesteps of (a) grasping the skin of a patient with one hand in the area ofdesired catheterization to fix the position of the skin and surroundingtissue relative to a vessel to be catheterized; (b) holding in the otherhand the catheter insertion device; (c) inserting the needle and thecatheter into the vessel until fluid flows from the vessel through theneedle; and. (d) moving the catheter into the vessel to a desiredposition. The method also comprises the step of retracting the bodyuntil the needle tip is covered by the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1a is a side view of a correct placement of a catheter withinthe vessel lumen.

[0019]FIG. 1b is a side view of an erroneous placement of a catheterthat does not initially penetrate a vessel.

[0020]FIG. 1c is a side view of an erroneous placement of a catheterthat penetrates completely through a vessel.

[0021]FIG. 2a illustrates an embodiment of a shaft used in connectionwith one embodiment of the present invention shown in FIGS. 3a-3 c.

[0022]FIG. 2b illustrates an embodiment of a body used in connectionwith one embodiment of the present invention shown in FIGS. 3a-3 c.

[0023]FIG. 3a illustrates an embodiment of a catheter insertion deviceready for insertion into a vessel.

[0024]FIG. 3b illustrates an embodiment of a catheter insertion devicewhere the shaft has been partially advanced.

[0025]FIG. 3c illustrates an embodiment of a catheter insertion devicewith the catheter released from the device.

[0026]FIG. 4 illustrates an exploded view of the catheter insertiondevice shown in FIGS. 3a-3 b.

[0027]FIGS. 5a and 5 b illustrate a fastening member used in connectionwith the present invention.

[0028]FIG. 5b illustrates the use of a clamp to seal the catheter afterit has been inserted within a vessel.

[0029]FIG. 6 illustrates a top view of the fastening member shown inFIGS. 5a and 5 b attached to a patient's arm with the catheter insertedthrough the skin and to a vessel.

[0030]FIG. 7 illustrates an exploded view of an alternate embodiment ofa catheter insertion device.

[0031]FIG. 7a illustrates a cross-sectional view of the shaft-clipengagement shown in FIG. 7.

[0032]FIG. 8a illustrates an embodiment of the catheter insertion deviceshown in FIG. 7 ready for insertion into a vessel.

[0033]FIG. 8b illustrates the embodiment of the catheter insertiondevice shown in FIG. 7 where the shaft has been partially advanced.

[0034]FIG. 8c illustrates the embodiment of the catheter insertiondevice shown in FIG. 7 with the catheter released from the device.

[0035]FIGS. 9a and 9 b illustrate the positioning of the gaugeindicators on the shaft relative to the insertion device body.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

[0036] Illustrations of construction, design, and methods of operationof the invention are set forth below with specific references to theFigures. However, it is not the intention of the inventor that the scopeof his invention be limited to these embodiments.

[0037] As used herein, “vertical” shall mean substantially along they-axis shown in the Figures, while “horizontal” shall mean substantiallyalong the x-axis shown in the Figures.

[0038]FIGS. 1a-1 c illustrate various positions encountered during anattempted placement of catheter 200 within a vessel 100. FIG. 1aillustrates desired catheter 200 placement. The operator insertscatheter 200/needle 300 combination, with needle tip 301 protruding fromcatheter tip 201, inserted through vessel wall 108 into vessel lumen120. To accomplish insertion, the operator prepares skin 110 with anantibacterial or sterilization agent. With one hand, the operatorlocates the vessel 100 to be catheterized and holds skin 110 and vessel100 in a fixed position to prevent vessel 100 from moving whenpunctured. With the other hand, the operator advances the catheter200/needle 300 combination by pushing it through skin 110 and advancingit until needle tip 301 enters the vessel lumen 120. The operator knowsthat needle 300 enters vessel 100 when he observes fluid enteringchambers 233 (FIGS. 3a, 3 b), 321 (FIG. 4) or needle head 320 (FIG. 7),or tubing connected thereto.

[0039] The next step is the most difficult and is where the majority ofmisstarts occur. As the operator advances catheter tip 201 into lumen120 (and deeper into vessel 100) the operator removes needle 300. Theoperator advances catheter 200 until catheter hub 310 is against theexterior of the skin 110 or until there is a vessel obstruction thatprevents further insertion. After an operator completes catheterization,he may connect catheter 200 to medication tubing, monitoring equipment,etc. at catheter hub 310.

[0040] The most difficult part of the procedure is successfullyinserting catheter tip 201 into vessel 100. FIGS. 1b and 1 c illustratetypical misstarts. In FIG. 1b, needle tip 301 advances into vessel 100.A backflow of blood is visible in collection chamber 321 indicatingvessel puncture. However, catheter tip 201 is not within vessel lumen120. Thus, when an operator removes needle 300, catheter 200 remainsoutside vessel wall 108, resulting in a misstart and requiringwithdrawal and re-puncture of skin 110 and vessel 100.

[0041]FIG. 1c illustrates a similar problem. Both needle tip 301 andcatheter tip 201 advance completely through vessel 100, leaving thecatheter tip 201 outside lower vessel wall 108 a. In this case, theoperator observes fluid backflow when needle tip 301 enters vessel 100.However, the fluid backflow ceases when needle tip 301 exits theopposite side of vessel 100. This process is further complicated if theoperator releases his grip on skin 110 and vessel 100 to handle needle300 or catheter 200 with both hands. If an operator releases skin 110before completion of the insertion, a properly placed catheter 200 willoften shift position and exit vessel 100.

[0042]FIG. 2a illustrates the shaft 210 used in connection with thepresent invention. Shaft 210 comprises a first end 213 and a catheterend 212. First end 213 is preferably a ring 213 a or other suitableshape to allow an operator to advance shaft 210, such as by using athumb. Catheter end 212 may releasably engage a clip 220 (or clip 501 or750 as described below).

[0043] Shaft 210 has a first locking member 214 positioned on at least aportion thereof that engages body 230 (shown in FIG. 2b). As theoperator advances shaft 210, first locking member 214 engages at least aportion of body passageway 232. First locking member 214 prevents anoperator from retracting shaft 210 and prevents needle tip 301 fromexiting from within the sheath 250. Alternatively or in addition, shaft210 may be advanced further so that needle tip 301 retracts furtherwithin sheath 250. Preferably, shaft 210 has a horizontal dimensionsized so that needle tip 301 is positioned within sheath 250 when firstlocking member 214 engages body 230.

[0044] Referring to FIG. 2a, needle sheath 250 is constructed as partof, or attaches to, shaft 210. Sheath 250 is preferably a tubular memberhaving a passageway 251 extending therethrough which has a horizontaldimension sized so that needle tip 301 is positioned within passageway251 when first locking member 214 engages body 230.

[0045] Sheath 250 is positioned so that as shaft 210 is advanced, sheath250 moves over needle tip 301. When first locking member 214 engagesbody 230, needle tip 301 is positioned completely within passageway 251to prevent accidental punctures to operators.

[0046] Sheath 250 is sized and positioned on shaft 210 so that needletip 301 is positioned within sheath 250 when first locking member 214engages body 230 and when needle tip 301 is withdrawn completely fromcatheter 200. Sheath 250 is positioned on shaft 210 a sufficientdistance from body 230 so that needle tip 301 is positioned withinsheath 250 when first locking member 214 engages body 230.

[0047] First locking member 214 and sheath 250 are positioned along thehorizontal axis of shaft 210 so that when first locking member 214engages body 230, sheath 250 slides over needle tip 301.

[0048]FIG. 2b illustrates body 230 having a passageway 232 that allowsshaft 210 to slidably engage body 230. Passageway 232 is preferably abore extending horizontally through body 230 along the same axis asneedle 300. In other embodiments not shown, body 230 may be configuredwith a slot along an exterior surface of body 230 or other suitableconfiguration that allows shaft 210 to slidably engage body 230 andoperate substantially as described herein.

[0049] Body 230 also has a pair of finger grips 231 to assist operatorsin gripping insertion device 340. A body fluid collection chamber 233attaches to or is constructed as part of body 230. Chamber 233 has afluid inlet 234 attachable to a fluid outlet in needle head 320 (seeFIG. 4). Chamber 233 also has a fluid outlet 235 that comprises aconnector 236 that allows chamber 233 to connect to tubing or otherdevices. Fluid inlet 234 is constructed so that needle head 320 willslide onto and fluidly and sealingly connect to chamber 234. Body 230engages needle 300 relative to hold it in place.

[0050] Backflow tubing 237 removably attaches to or is constructed aspart of chamber 233 as shown in FIGS. 2b, and 3 a-3 c (in FIGS. 7, 8a-8c in embodiments described later). Backflow tubing 237 has a closeableor closed end, such as connector 236, and allows extended viewing offluid flow through backflow tubing 237, insuring proper needle tipplacement in the patient's blood vessel. As long an operator views fluidflowing into backflow tubing 237, the operator knows that catheter tip201 is positioned intravenously.

[0051] Backflow tubing 237 can be of various sizes and lengths,preferably at least 1 cubic centimeter (cc), more preferably about 3 cc.The exact size and volume of backflow tubing 237 will depend on theuser's desires, but backflow tubing 237 should be of sufficient lengthto allow a user multiple attempts at catheterization so that extravolume exists within backflow tubing 237 for the extra blood flow thatwill occur with more than one attempt at properly inserting the catheterin the blood vessel. Backflow tubing 237 may be used with any of theembodiments described herein.

[0052] Medical personnel may use conventional needles 300 with thepresent invention. Viewing FIG. 4, needles 300 generally comprise ahollow shaft 322 extending between needle tip 301 and needle head 320 sothat fluid may flow from tip 301 through shaft 322 and into needle head320. Needle head 320 may also comprise a fluid chamber 321 as shown.Needle 300 slidingly inserts within catheter 200 so that only needle tip301 protrudes through catheter tip 201 when insertion device 340 insertswithin vessel 100 as shown in FIG. 5a.

[0053] Viewing FIG. 4, in operation, with shaft 210 fully retracted, theoperator sealing attaches needle 300 to body fluid inlet 234 via needlehead 320. Needle 300 inserts coaxially through catheter 200 until needletip 301 protrudes through catheter tip 201. Clip 220 (or clip 501) gripscatheter 200 and releasably attaches to catheter end 212 of shaft 210. Alip 312 prevents clip 220 from disengaging catheter 200, althoughadhesive material or other attachment means may be used to ensure thatcatheter 200 remains attached to clip 220.

[0054] An operator prepares skin 110 surrounding the insertion pointwith an antibacterial agent. With one hand, the operator locates vessel100 to be catheterized and holds skin 110 and vessel 100 in a fixedposition to prevent vessel 100 from moving when punctured. With theother hand, the operator advances insertion device 340 by inserting andpushing needle tip 301 and catheter tip 201 through skin 110 andadvances them until needle tip 301 enters vessel lumen 120. The operatorobserves that needle tip 301 enters vessel 100 by observing fluidentering needle fluid chamber 321 and backflow tubing 237.

[0055] Viewing FIGS. 3a-3 c, while blood enters needle head chamber 321and body fluid chamber 233, the operator's thumb advances shaft 210 asthe index and middle fingers hold finger grips 231 just as the operatorwould use an ordinary syringe. A gauge indicator 304 on shaft 210indicates the safe distance that catheter tip 201 may insert withinvessel 100 before withdrawing needle 300 without causing a misstart.Gauge indicators 304 may comprise visible lines configured around thediameter of shaft 210 or other devices as described herein.

[0056] As shown in the blown up portion of FIG. 5a, there is a distancebetween needle tip 301 and catheter tip 201, referred to herein as thetip distance and marked as β, that exists between tips 201, 301 when theneedle-catheter combination is ready for insertion into a blood vessel.The tip distance also equals the relative distance that the shaft may beadvanced before needle tip 301 retracts completely within catheter 200and past catheter tip 201.

[0057] After needle tip 301 has retracted within catheter 200 and pastcatheter tip 20 t, the operator should preferably not reinsert catheter200. If catheter 200 is reused, needle tip 301 could shear off portionsof catheter 200 and catheter tip 201 during reinsertion.

[0058] Gauge indicator 304 is positioned a distance, referred to as safedistance α, from an end of body 230 as shown in FIGS. 9a and 9 b so thatthe operator knows the distance that the shaft can be advanced withoutrequiring the original catheter 200 and needle 300 to be discarded.

[0059] In the embodiment shown in FIG. 9a, gauge indicators 304 arepositioned exterior of body 230 when device 340 is ready to insertcatheter 200 so that if gauge indicator 304 substantially enters body230, the operator will know he has exceeded safe distance a and willrequire a new catheter 200 and needle 300 if reinsertion is necessary.

[0060] Another embodiment is shown in FIG. 9b. Gauge indicator 304 ispositioned along shaft 210 within body 230 when device 340 is ready toinsert catheter 200 so that if gauge indicator 304 substantially exitsbody 230, the operator will know he has exceeded safe distance α andwill require a new catheter 200 and needle 300 if reinsertion isnecessary.

[0061] In other embodiments, gauge indicators 304 may comprise slightlyraised annular rings positioned around shaft 210. When safe distance ahas been exceeded, the operator will feel a slight “bump” as appropriategauge indicator 304 engages body 230, informing the operator that needle300 and catheter 200 must be replaced. The operator must restart theinsertion process. As long as the operator does not feel the bump, theoperator may continue the insertion process.

[0062] Alternatively, gauge indicators 304 may be configured as secondlocking mechanisms so that if safe distance a is exceeded, needle tip301 will be “locked” and prevented from extending from catheter tip 201by retraction of shaft 210. Each gauge indicator 304 may be configuredas a separate detent or locking mechanism in embodiments with multiplegauge indicators 304 (see FIG. 9a).

[0063] Because insertion device 340 may interchangeably work withdifferent sized needles 300 and catheters 200, multiple gauge indicators304 may be positioned along shaft 210 as shown in FIG. 9a to accommodatechanges in tip distance β (and safe distance α accordingly) resultingfrom the use of larger or smaller needles 300 and catheters 200.

[0064] “Advance” and derivatives thereof, when referring to the movementof shaft 210 means the relative movement between needle 300 and shaft210 along the horizontal axis, whereby shaft 210 moves horizontally suchthat first locking member 214 advances toward body 230 and sheath 250advances toward needle tip 301. Alternatively and in addition, one mayview this relative movement as needle tip 301 retracting within sheath250.

[0065] First locking member 214 engages body 230 so that shaft 210 maybe advanced to further retract needle tip 301 within sheath 250, butshaft 210 may not retract. Although first locking member 214 is shownpositioned on shaft 210, shaft 210 and body 230 may be configured in avariety of other ways as long as shaft 210 and body 230 “lock” toaccomplish the purposes described herein.

[0066] After the operator has positioned catheter 200 within vessel 100,the operator advances shaft 210 until catheter 200 is properlypositioned in vessel 100. Then, while preferably holding shaft 210 inplace, the operator retracts body 230 to retract needle tip 301 fromwithin vessel 100 and into sheath 250. The operator then uses firstlocking member 214 to lock body 230 and shaft 210. First locking member214 preferably engages body 230 so that it fixes the position of shaft210 so that shaft 210 does not cause needle tip 301 to protrude fromsheath 250. Viewing FIG. 3c, after the operator locks shaft 210 withinbody 230 (locking needle tip 301 within sheath 250), the operatorreleases clip 220 (or clip 501 or clip 750) from shaft 210. Catheter 200is ready for attachment to medication tubing, monitoring equipment, etc.

[0067] The configuration of the embodiments of the present inventionallow an operator to use a single hand to operate catheter insertiondevice 340 and thus decrease the number of misstarts.

[0068] Viewing FIGS. 5a and 5 b, after the operator positions catheter200 within vessel 100, the operator may position catheter 200 relativeto skin 110 using a fastening member 500. In this embodiment, a clip 501replaces clip 220. Clip 501 has an opening 502 therein that gripscatheter 200 within opening 502 so that clip 501 grips and holdscatheter 200. Opening 502 is sized and configured so that needle 300 mayinsert through catheter 200 as previously described. When clip 501 gripscatheter 200, lip 312 preferably rests outside opening 502 as shown inFIG. 5b.

[0069] One or more adhesive wings 503 attach to clip 501 (shown in araised position in FIG. 5a). Wings 503 have an adhesive side 504 that iscovered by protective strips 504 a. Viewing FIG. 6, after the operatorproperly positions catheter 200 within vessel 100, the operator foldswings 503 toward skin 110 on appendage 600. The operator removesprotective strip 504 a, exposing adhesive side 504. The operatorpositions adhesive sides 504 against skin 110 thereby fixing theposition of catheter 200.

[0070] As shown in FIG. 5b, a clamp 660 may be positioned on catheter200 to fluidly seal catheter 200 when catheter 200 has been insertedwithin a vessel. Clamp 660 prevents blood backflow from the catheterizedvessel to the environment. Clamp 660 may be freely positionable or maymount onto clip 501 at bore 661 using clamp stem 662 which slidablyengages bore 661 as shown in FIG. 5b (or onto clip 750 (not shown)).Although clamp 660 is shown in use with the present invention, it may beused in connection with other conventional catheters and catheterinsertion devices. Clamp 660 is preferably configured so that it doesnot crush or deform catheter 200 when engaged therewith after needle 300has been removed from within catheter 200 but configured so that itprovides sufficient compression of hollow catheter 200 to seal it.

[0071] Another embodiment of the present invention is shown in FIG. 7.Shaft 710 comprises a shaft having a catheter end 711 and a ring-shapedfirst end 701. Shaft 710 slidingly inserts through body 703 via bore 706which extends horizontally through body 703. Body 703 is configured witha pair of indentations 704 along the sidewalls of body 703 to assist anoperator in gripping body 703 much like finger grips 231 previouslydescribed. A U-shaped slot 705 extends along the bottom surface of body703. Slot 705 is sized to allow needle head 320 to fit therein,preferably allowing needle head 320 to snap-fit within slot 705 so thatneedle 300 is fixedly positioned relative to body 703. Connector end 390protrudes from body 703 so that needle head 320 may fluidly connect tobackflow tubing 237 to provide an extended backflow chamber for bloodduring the insertion process as previously discussed.

[0072] Slot 705 may also be constructed as a bore extending horizontallythrough body 703. If a bore construction is used, the bore must beconfigured to allow needle 300 to be inserted therethrough while at thesame time fixing the position of needle 300 relative to body 703 orallow needle 300 to engage body 703 as shown.

[0073] As discussed in previous embodiments, a locking member 780 ispreferably positioned near first end 701 so that shaft 710 lockablyengages body 703 when needle tip 301 has fully retracted with slot 707of sheath 702. Sheath 702 has a horizontal dimension sized so thatneedle tip 301 is positioned within slot 707 when locking member 780engages body 703. Sheath 702 is positioned so that as shaft 710 isadvanced, sheath 702 slides over needle tip 301. When locking member 780engages body 703, needle tip 301 is positioned completely within slot707 to prevent accidental punctures to operators. Sheath 702 is sizedand positioned on shaft 710 so that needle tip 301 is positioned withinsheath 702 when locking member 780 engages body 703 and when needle tip301 is withdrawn completely from catheter 200. Sheath 702 is positionedon shaft 710 a sufficient distance from body 703 so that needle tip 301is positioned within sheath 710 when locking member 780 engages body703.

[0074] Sheath 702 is also configured with a U-shaped slot 707 extendingalong its bottom edge. Sheath 702 has a first bore 709 that allowscatheter end 711 of shaft 710 to insert therethrough, allowing shaft 210to slidably engage sheath 702. First bore 709 is configured so thatsheath 702, though slidingly positionable on shaft 710, is removablyattached thereto when insertion device 340 is in use.

[0075] Slot 707 may also be constructed as a bore extending horizontallythrough sheath 750. If a bore configuration is used, the bore ispreferably configured to align with slot 751 in clip 750 to allowcatheter lip 312 to be positioned within slot 707 so that needle tip 301is not exposed after it has been removed from within catheter 200.

[0076] Clip 750 has slots 751, 752 configured along its upper and lowerends. Slot 707 allows catheter 200 to snap into slot 751. Slot 752 isconfigured to receive catheter end 711 of shaft 710. Viewing FIG. 7a, ahole 754 is configured within clip 750 to receive shaft stem 720, whichsnaps into bore 754 so that shaft 710 releasably attaches to clip 750during operation of catheter insertion device 340. Although clip 750 isshown with slots 751, 752, other configurations may be used for clip 750to allow clip 750 to reasonably engage both catheter 200 and shaft 710.

[0077]FIG. 8a illustrates insertion device 340 ready for deployment ofcatheter 200 within a vessel 100 with needle tip 301 protruding throughcatheter tip 201. FIG. 8b illustrates the positioning of the componentsof first component 790 when locking member 780 has engaged body 703,thereby locking shaft 710 and body 703. Needle tip 301 is shownpositioned within sheath 702. FIG. 8c illustrates clip 750 grippingcatheter 200 and detached from first component 790, so that firstcomponent 790 can be properly disposed. Fastening member 500 can also beincorporated into this embodiment and comprises wings 755 attached toclip 750, which are shown folded down ready for fastening to a patient'sskin.

[0078] One or more adhesive wings 755 attach to clip 750 (shown in araised position in FIGS. 8a and 8 b). Wings 755 have an adhesive side756 that is covered by protective strips 757.

[0079] The embodiment shown in FIGS. 7 and 8a-8 c operates as follows.An operator prepares skin 110 surrounding the insertion point with anantibacterial agent. The operator removes protective strip(s) 757,exposing adhesive side(s) 756. With one hand, the operator locatesvessel 100 to be catheterized and holds skin 110 and vessel 100 in afixed position to prevent vessel 100 from moving when punctured. Withthe other hand, the operator advances the device 340 by inserting andpushing needle tip 301 and catheter tip 201 through skin 110 andadvances them until needle tip 301 enters vessel lumen 120. The operatorobserves that needle tip 301 enters vessel 100 by observing fluidentering needle head chamber 321 and/or tubing connected at connectorend 390. While blood enters needle head chamber 321, the operator'sthumb advances shaft 710 as the index and middle fingers holdindentations 704 similar to how an operator would use an ordinarysyringe. One or more gauge indicators 770 may be positioned on shaft 710and operate as previously discussed.

[0080] After the operator has positioned catheter 200 within vessel 100,the operator advances shaft 710 until catheter 200 is properly insertedwithin vessel 100. Then, while preferably holding shaft 710 in place,the operator retracts body 703 to retract needle tip 301 from withinvessel 100 and into sheath 702. The operator then uses locking member780 to lock body 703 and shaft 710. Locking member 780 preferablyengages body 703 so that it fixes the position of shaft 710 so thatshaft 710 does not cause needle tip 301 to protrude from sheath 702.After the operator locks shaft 710 within body 703 (locking needle tip301 within slot 707 of sheath 702), the operator releases clip 750 fromshaft 710. Catheter 200 is ready for attachment to medication tubing,monitoring equipment, etc.

[0081] Viewing FIG. 8c, after the operator properly positions catheter200 within vessel 100, the operator removes protective strips 757 andfolds wings 755 downward to position catheter 200. Shaft 710 is thenreleased from clip 750 by removing stem 720 from within hole 754 in clip750 (see FIG. 7a). The operator positions adhesive sides 504 againstskin 110 thereby fixing the position of catheter 200 relative to vessel100.

[0082] Although the preferred embodiment has been described, it will beappreciated by those skilled in the art to which the present inventionpertains that modifications, changes, and improvements may be madewithout departing from the spirit of the invention defined by theclaims.

I claim:
 1. A catheter insertion device comprising: a. a shaft having afirst end and a catheter end, said catheter end configured to releasablyengage a hollow catheter having a tip; b. a sheath positioned on saidshaft, said sheath configured to have a passage therethrough, saidsheath positioned to align said passage with said catheter; c. a bodyslidably positioned on said shaft, said body attachable to a needle andconfigured to align a needle with said passage of said sheath and withsaid catheter; wherein a needle, said sheath, said shaft and saidcatheter are sized and spaced to position a needle tip of a needlebeyond said catheter tip when said body is advanced toward said catheterend of said shaft and to remove the needle tip from within said catheterand to position the needle tip within said passage of said sheath whensaid body is retracted toward said first end of said shaft.
 2. A deviceaccording to claim 1 wherein said shaft further comprises a clipattaching said catheter to said shaft.
 3. A device according to claim 2wherein said clip is engageable with said sheath.
 4. A device accordingto claim 2 wherein said clip is engageable with said shaft.
 5. A deviceaccording to claim 2 wherein said clip is configured to fluidly sealsaid catheter when a needle positioned within said catheter has beenremoved therefrom.
 6. A device according to claim 2 further comprising aclamp configured to fluidly seal said catheter when a needle positionedwithin said catheter has been removed therefrom.
 7. A device accordingto claim 2 wherein said body comprises a shaft bore extendingtherethrough, said shaft slidably engaging said body via said shaftbore.
 8. A device according to claim 2 wherein said body has exteriorsurface, said body comprising at least one slot configured along saidexterior surface, said slot adapted to allow said shaft to movablyengage said body.
 9. A device according to claim 7 wherein said bodycomprises a fluid chamber comprising a fluid inlet and a fluid outlet,said fluid inlet connectable to said needle.
 10. A device according toclaim 1 further comprising at least one fastening member configured tosubstantially fix the position of said catheter.
 11. A device accordingto claim 1 further comprising at least one locking member that preventssaid needle tip from advancing from said sheath.
 12. A device accordingto claim 1 wherein said sheath is sized so that said needle tip ispositioned within said sheath when said locking member engages saidbody.
 13. A device according to claim 1 further comprising a needleengageable with said body, said needle insertable through said passagein said sheath and insertable through said catheter.
 14. A deviceaccording to claim 1 wherein said sheath is positioned so that the tipof said needle is positioned within said sheath when said needle tip iswithdrawn from said catheter.
 15. A device according to claim 1 whereinsaid shaft has a horizontal dimension sized so that said needle tip ispositioned within said sheath when said locking member engages saidbody.
 16. A device according to claim 10 wherein said fastening membercomprises at least one section of adhesive material positioned on saidcatheter, said section adapted to adhere to a patient to substantiallyfix the position of said catheter.
 17. A device according to claim 16wherein said fastening member comprises at least one section of adhesivematerial positioned on said clip, said section adapted to adhere to apatient to substantially fix the position of said catheter.
 18. A deviceaccording to claim 1 further comprising a backflow chamber.
 19. A deviceaccording to claim 18 wherein said backflow chamber has a volume of atleast 1 cc.
 20. A device according to claim 1 further comprising atleast one gauge indicator positioned on said shaft.
 21. A deviceaccording to claim 20 wherein said gauge indicator comprises one or moreannular rings positioned around said shaft.
 22. A method for intravenousinsertion of a catheter using a catheter insertion device comprising: a.a shaft having a first end and a catheter end, said catheter endconfigured to releasably engage a hollow catheter having a tip; b. asheath positioned on said shaft, said sheath configured to have apassage therethrough, said sheath positioned to align said passage withsaid catheter; c. a body slidably positioned on said shaft, said bodyattachable to a needle and configured to align a needle with saidpassage of said sheath and with said catheter; wherein a needle, saidsheath, said shaft and said catheter are sized and spaced to position aneedle tip of a needle beyond said catheter tip when said body isadvanced toward said catheter end of said shaft and to remove the needletip from within said catheter and to position the needle tip within saidpassage of said sheath when said body is retracted toward said first endof said shaft; said method comprising the steps of i. grasping the skinof said patient with one hand in the area of desired catheterization tofix the position of said skin and surrounding tissue relative to avessel to be catheterized; ii. holding in the other hand said catheterinsertion device; iii. inserting said needle and said catheter into saidvessel until fluid flows from said vessel through said needle; and, iv.advancing said catheter into said vessel to a desired position;
 23. Amethod according to claim 22 further comprising the step of retractingsaid body until said needle tip is covered by said sheath.
 24. A methodaccording to claim 23 further comprising the step of releasing saidcatheter from said shaft.
 25. A method according to claim 24 furthercomprising the step of fastening said catheter with a fastening member.26. A medical device comprising: a. a catheter insertable within avessel; b. a catheter insertion device engageable with said catheter; c.a clamp engageable with said catheter insertion device, said clampconfigured to fluidly seal said catheter when said catheter has beenpositioned within a vessel and when a needle used to insert saidcatheter within a vessel has been removed from within said catheter. 27.The device according to claim 21 wherein said gauge indicator comprisesat least one locking mechanism.